Ex Parte Copp-Howland

Patent Trial and Appeal Board

Aug 16, 2016

13677831 (P.T.A.B. Aug. 16, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/677,831 11115/2012
55748 7590 08/18/2016
Covidien
Attn: IP Legal Department
15 Hampshire Street, Bldg. 4A
Mansfield, MA 02048
FIRST NAMED INVENTOR
Warren Copp-Howland
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
HKN-01670(2)(1502-676DIV) 2675
EXAMINER
ALAWADI, SARAH
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
08/18/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
iplegalus@covidien.com
docket@cdfslaw.com
medtronic_mitg-pmr_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte WARREN COPP-HOWLAND 1
Appeal 2015-000462
Application 13/677 ,831
Technology Center 1600
Before ERIC B. GRIMES, TA WEN CHANG, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a medical
electrode where the conductive composition includes a hydrogel, a bioactive
agent and a penetration enhancer, which have been rejected as obvious and
unpatentable under the judicially created doctrine of obviousness-type
double patenting. We have jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
1 Appellant identifies the Real Party in Interest as Covidien LP. (Appeal Br.
2.)
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Application 13/677 ,831
STATEMENT OF THE CASE
Bioactive agents, such as drugs, are known to be administered
topically. (Spec. i-f 5.) Hydrogels "have ... been used for the delivery of
bioactive agents." (Id. at i-f 4.)
Appellant's Specification notes that "[t]he stratum comeum layer of
the skin may limit the effectiveness of transdermal delivery of bioactive
agents." (Id. i-f 5.)
"Medical electrodes transmit electrical signals or currents to or from a
patient's skin and an external medical apparatus." (Id. at i-f52.) According to
Appellant's Specification, "the electric current developed by an electrode
may further enhance the release and/or transdermal delivery of a bioactive
agent." (Id. at i-f 54.)
Claims 1-3, 5, and 7-10 are on appeal. Claim 1 is representative and
reads as follows:
1. A medical electrode comprising:
a substrate;
a conductive composition on at least a portion of a surface
of the substrate, the conductive composition comprising at least
one hydrogel comprising:
a polymeric component compnsmg a copolymer
comprising a first monomer comprising a mixture of acrylic acid
and a salt thereof, present in an amount of from about 8 weight
% to about 85 weight % of the copolymer, and a second
monomer of the formula CH2=CHC(O)XR, in which X is 0 or
NH and R is an unsubstituted or substituted alkyl group of from
about 1 to about 5 carbon atoms present in an amount of from
about 15 weight % to about 92 weight % of the copolymer;
at least one penetration enhancer selected from the group
consisting of sulfoxides, alcohols, pyrrolidones, laurocapram,
solvents, fatty alcohols, amides, amino acids, azones, oils, fatty
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Application 13/677 ,831
acids and their esters, macrocycles, phospholipids, glycols, and
combinations thereof; and
at least one bioactive agent.
(Appeal Br. 8.)
The following grounds of rejection by the Examiner are before us on
review:
Claims 1-3, 5, and 7-10 under 35 U.S.C. § 103(a) as unpatentable
over Copp-Howland2 and Cassel. 3
Claims 1-3, 5, and 7-10 on the ground of non-statutory obviousness-
type double patenting over claims 1-12 and 22 of US 8,419,982 B2, issued
Apr. 16, 2013.
Claims 1-3, 5, and 7-10 on the ground of non-statutory obviousness-
type double patenting over claims 1-15, 16-22, 24--29, and 31 of US
7,761,131 B2, issued July 20, 2010, and Cassel.
DISCUSSION
Obviousness
The Examiner finds that Copp-Howland teaches a conductive
hydrogel composition comprising a claimed polymer and that the
composition can be used with medical electrodes for pain management and
drug delivery via iontophoresis. (Final Action 8, 10; Ans. 4--6.) The
Examiner acknowledges that Copp-Howland does not teach a specific
bioactive agent or the inclusion of a penetration enhancer in the conductive
composition. (Final Action 8; Ans. 5.)
2 Copp-Howland, US 2007/0282188 Al, published Dec. 6, 2007.
3 Cassel, US 2006/0029654 Al, published Feb. 9, 2006.
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Application 13/677 ,831
The Examiner finds that Cassel teaches a hydrogel carrier
composition used with a transdermal patch that also includes an anesthetic,
such as benzocaine. (Final Action 9; Ans. 5.) Cassel also teaches the
inclusion of penetration enhancers, such as dimethylsulfoxide (DMSO), in
the hydrogel composition which "aid in treatment effectiveness by
facilitating delivery of the anesthetic and accelerate[] the delivery of a
substance through the skin." (Final Action 10 (citing Cassel i-f 35); Adv.
Act. 3; Ans. 5.) The Examiner finds that the transdermal patch taught by
Cassel is useful for treating "deep tissue damage and pain from sports
injuries that cannot be treated with topical anesthetics." (Ans. 6.)
Furthermore, the Examiner finds that Cassel teaches that electric current
(such as is applied in iontophoresis) can be used to deliver the active agent
through the skin. (Final Action 12 (citing Cassel i-f 39); Adv. Act. 3; Ans. 6.)
In light of the foregoing, the Examiner finds that it would have been
obvious to include (1) an anesthetic, such as benzocaine, as the bioactive
agent and (2) DMSO as a penetration enhancer in the hydrogel composition
of Copp-Howland in order to achieve a pain-reducing composition with
accelerated drug delivery that can be applied topically to treat deep tissue
damage and pain. (Final Action 9-10; Adv. Act. 3; Ans. 6-7.) The
Examiner finds that there would have been a reasonable expectation of
success for including a penetration enhancer and benzocaine with an
electrode containing the hydro gel of Copp-Howland, because both
references teach delivery of drugs through hydrogels and indicate that
electric current can be applied to assist delivery of the drug substance.
(Final Action 11-12; Adv. Act. 3--4; Ans. 7.)
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Application 13/677 ,831
We agree with the Examiner's factual findings and conclusion that the
claimed medical electrode would have been obvious.
Appellant argues that the Examiner's rejection is in error because (a)
"Copp-Howland does not disclose or suggest a medical electrode that
includes a penetration enhancer" and "nowhere does Cassel disclose [or
suggest] electrodes ... or disclose or suggest the recited polymer component
[of the hydrogel]" (Appeal Br. 4--5; Reply Br. 4), (b) that the "references
teach different uses/purposes i.e., electrodes in Copp-Howland, and
anesthetic patches for topical treatment of pain resulting from sports injuries
in Cassel" (Appeal Br. 5; Reply Br. 3), and (c) that the Examiner has used
"impermissible hindsight" because "[ t ]he connection the Examiner tries to
make between these references is not found in the references themselves"
(Appeal Br. 6; Reply Br. 3). These arguments are not persuasive for the
reasons that follow.
We disagree with Appellant that the references teach different
purposes. As the Examiner explained, both Copp-Howland and Cassel
discuss the use of their hydro gels for pain management, as well as assisting
drug delivery through intact skin via iontophoresis. (Ans. 9; Copp-Howland
i-f 53; Cassel i-f 39). Appellant's argument (Appeal Br. 5, Reply Br. 3)
ignores the iontophoretic teaching in Cassel as well as Copp-Rowland's
teaching that its electrode can be used for drug delivery through
iontophoresis. "'It is impermissible within the framework of section 103 to
pick and choose from any one reference only so much of it as will support a
given position, to the exclusion of other parts necessary to the full
appreciation of what such reference fairly suggests to one of ordinary skill in
the art."' In re Hedges, 783 F.2d 1038, 1041 (Fed. Cir. 1986) (quoting In re
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Application 13/677 ,831
Wesslau, 353 F.2d 238, 241 (CCPA 1965)). When Copp-Howland and
Cassel are read for all that they teach, it is apparent that they are in the same
or similar fields of endeavor and are thus analogous art. In re Clay, 966
F.2d 656, 658-59 (Fed. Cir. 1992) ("Two criteria have evolved for
determining whether prior art is analogous: (1) whether the art is from the
same field of endeavor, regardless of the problem addressed, and (2) if the
reference is not within the field of the inventor's endeavor, whether the
reference still is reasonably pertinent to the particular problem with which
the inventor is involved."). Consequently, we agree with the Examiner that
one of ordinary skill in the art would have reasonably combined the
teachings of Cassel with Copp-Howland.
Moreover, Appellant's argument that Copp-Howland does not teach
the use of penetration enhancers or that Cassel does not teach the use of the
claimed polymer of the hydrogel (Appeal Br. 4--5; Reply Br. 4) is
unavailing. "Non-obviousness cannot be established by attacking references
individually where the rejection is based upon the teachings of a
combination of references." In re Merck & Co., 800 F.2d 1091, 1097 (Fed.
Cir. 1986). Instead, both references must be read for what they fairly teach
"in combination with the prior art as a whole." Id.; see also In re Lemelson,
397 F.2d 1006, 1009 (1968) (references are "relevant for all they contain").
While Cassel does not "disclose electrodes," we agree with the
Examiner that Cassel's teaching that drugs can be delivered by electric
currents using iontophoresis suggests that the hydro gels of Cassel, which
include penetration enhancers such as DMSO, are suitable for use with
electrodes. The foregoing, in combination with Copp-Rowland's teaching
of the use of hydro gels with electrodes, including for delivery of drugs and
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Application 13/677 ,831
for pain management, would provide one of ordinary skill with a reasonable
expectation of success in including the penetration enhancer DMSO in the
hydro gel composition of Copp-Howland.
For the same reasons, we disagree with Appellant's argument that the
Examiner's rejection is based on hindsight. "Any judgment on obviousness
is in a sense necessarily a reconstruction based upon hindsight reasoning, but
so long as it takes into account only knowledge which was within the level
of ordinary skill at the time the claimed invention was made and does not
include knowledge gleaned only from applicant's disclosure, such a
reconstruction is proper." In re McLaughlin, 443 F.2d 1392, 1395 (CCPA
1971). As discussed in the foregoing, the Examiner's assertion of
motivation and reasonable expectation of success derives from the teachings
specifically set forth in Copp-Howland and Cassel. For the reasons
discussed, we are not persuaded of Examiner error, and accordingly, we
affirm the Examiner's rejection of independent claim 1.
Claims 2, 3, 5, and 7-10 have not been argued separately and
therefore fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
Obviousness-type Double Patenting
Appellant does not contest either of the obviousness-type double
patent rejections. (Appeal Br. 7 .) Therefore, we summarily affirm those
rejections.
SUMMARY
We affirm the rejection of claims 1-3, 5, and 7-10 under 35 U.S.C.
§ 103(a) as unpatentable over Copp-Howland and Cassel.
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We affirm the rejection of claims 1-3, 5, and 7-10 on the ground of
nonstatutory obviousness-type double patenting as unpatentable over claims
1-12 and 22 of US 8,419,982 B2.
We affirm the rejection of claims 1-3, 5, and 7-10 on the ground of
nonstatutory obviousness-type double patenting as unpatentable over claims
1-15, 16-22, 24--29, and 31 of US 7,761,131 B2 in view of Cassel.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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